Krajina: Európska únia
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
cariprazine hydrochloride
Gedeon Richter
N05AX15
cariprazine
Psycholeptics
Schizophrenia
Reagila is indicated for the treatment of schizophrenia in adult patients.
Revision: 7
Authorised
2017-07-13
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER REAGILA 1.5 MG HARD CAPSULES REAGILA 3 MG HARD CAPSULES REAGILA 4.5 MG HARD CAPSULES REAGILA 6 MG HARD CAPSULES cariprazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Reagila is and what it is used for 2. What you need to know before you take Reagila 3. How to take Reagila 4. Possible side effects 5. How to store Reagila 6. Contents of the pack and other information 1. WHAT REAGILA IS AND WHAT IT IS USED FOR Reagila contains the active substance cariprazine and belongs to a group of medicines called antipsychotics. It is used to treat adults with schizophrenia. Schizophrenia is a disease characterised by symptoms such as hearing, seeing or sensing things which are not there (hallucination), suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious, tense, or not being able to start or keep up planned activities, unwillingness to speak, lack of emotional response to a situation that would normally stimulate feelings in others. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REAGILA DO NOT TAKE REAGILA - if you are allergic to cariprazine or any of the other ingredients of this medicine (listed in section 6). - if you are taking medicines used to treat: - hepatitis caused by the hepatitis C virus (medicines containing boceprevir and telaprevir) - bacterial infections (medicines containing clarithromycin, telithromycin, erythromycin and nafcillin) - Prečítajte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Reagila 1.5 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine. Reagila 3 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine. Excipient with known effect Each hard capsule contains 0.0003 mg Allura red AC (E 129). Reagila 4.5 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine. Excipient with known effect Each hard capsule contains 0.0008 mg Allura red AC (E 129). Reagila 6 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine. Excipient with known effect Each hard capsule contains 0.0096 mg Allura red AC (E 129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Reagila 1.5 mg hard capsules ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink. The capsules are filled with white to yellowish white powder mixture. Reagila 3 mg hard capsules ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink. The capsules are filled with white to yellowish white powder mixture. 3 Reagila 4.5 mg hard capsules ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink. The capsules are filled with white to yellowish white powder mixture. Reagila 6 mg hard capsules ‘Size 3’ (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on th Prečítajte si celý dokument